MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA25 A.CONTROL RESERV.; HYDROCEPHALUS VALVES

Model Number	FX435T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 sys w/sa25 a.Control reserv.(#fx435t) was implanted during the procedure on (b)(6) 2005.According to the complainant, the valve was believed to be disfunction.The patient underwent a revision procedure on (b)(6) 2017 the complainant device was returned to the manufacturer for evaluation.Further details were not provided.Height: (b)(6).
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: visual inspection except scratches no significant deformations or damage of the valves were detected during the visual inspection.The measurement of the plane parallelism could confirm this.Permeability test a permeability test has indicated that both valves have blockages.Computer controlled test to investigate over/under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.Because both valves are not permeable, a computer controlled test is not possible.Adjustment test the progav® was tested and is adjustable to all specified pressures.Braking force and brake function test the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Results first, we performed a visual inspection of the progav® shunt system.No significant deformations or damage of the valves were detected during the visual inspection.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.Both valves have a blockage, therefore the computer controlled test is not possible.The progav® was tested and is adjustable to all specified pressures, the brake function is fully operational and the braking force is within the given tolerances.Finally, we have dismantled the valves.Inside the progav® valve we have found a small amount of build up substances,whereas in the shuntassistant® significant residues of blood were detected.Based on our investigation, we confirm the presence of occlusion in the system at the time of investigation.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hg-therapy by shunt implants.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 SYS W/SA25 A.CONTROL RESERV.
• Common Device Name: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12918744
• Report Number: 3004721439-2021-00792
• Device Sequence Number: 5222914
• Product Code: JXG
• UDI-Device Identifier: 04041906137335
• UDI-Public: 4041906137335
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2022
• Device Model Number: FX435T
• Device Catalogue Number: FX435T
• Device Lot Number: 20033805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 MO
• Patient Sex: Unknown
• Patient Weight: 50 KG